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Ovarian Epithelial CarcinomaPhase 2NCT05763199

Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®) in Ovarian Cancer Patients on Adjuvant Chemotherapy

A Phase 2 study testing AHCC and Chemotherapy in people with Ovarian Epithelial Carcinoma and Fallopian Tube Carcinoma, run by University of California, Davis at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a pilot phase, randomized, double-blinded feasibility pilot study of AHCC in participants with ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
AHCC and Chemotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Aug 2023to 1 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed epithelial ovarian, fallopian tube or peritoneal carcinoma
  • High-grade or low-grade serous, mucinous, endometrioid, clear cell, mixed or other histologies allowed
  • Clinical stage I-IV at diagnosis
  • Treatment decision to include standard-of-care adjuvant chemotherapy after primary or interval debulking surgery, or initial staging surgery. Chemotherapy should include a platinum and a taxane doublet.
  • Neoadjuvant chemotherapy is allowed (no washout period will be required)
  • Any combination of platinum and taxane doublet is allowed (i.e., carboplatin, cisplatin, paclitaxel, or docetaxel)
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  • Different schedules of platinum and taxane doublet are allowed (i.e., every 21 days, dose-dense or weekly)
  • Bevacizumab is allowed
  • Age greater than or equal to 18 years of age
  • English or Spanish-speaking individuals
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
  • Organ and bone marrow function defined by:
  • Leukocytes greater than or equal to 2,500/µL
  • Absolute neutrophil count greater than or equal to 1,000/µL
  • Platelets greater than or equal to 75,000/µL
  • Hemoglobin greater than or equal to 8 g/dL
  • Total bilirubin less than or equal to 1.5 × institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level less than or equal to 3 x ULN may be enrolled)
  • Aspartate aminotransferase (AST)/ alanine transaminase (ALT) less than or equal to 3 × ULN (AST and/or ALT less than or equal to 5 x ULN for patients with liver involvement)
  • Alkaline phosphatase less than or equal to 2.5 × ULN (less than or equal to 5 x ULN for patients with documented liver involvement or bone metastases)
  • Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 30 mL/min by Cockcroft-Gault or 30 mL/min/1.73m2
  • Individuals of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation (including dosing interruptions) and for at least 5 months (150 days) after the last dose of study agent or the duration specified in the United Surgical Partners International (USPI) for any of the agents used in the adjuvant standard-of-care regimen, whichever is longest. Patients must agree to refrain from egg donation during this timeframe.
  • Ability to understand and the willingness to sign a written informed consent document
  • Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have:
  • A stable regimen of highly active anti-retroviral therapy (HAART)
  • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  • A cluster of differentiation 4 (CD4) count above 250 cells/µL and an undetectable HIV viral load on standard polymerase chain reaction (PCR)-based tests within the last year.

Who cannot join

  • History of allergic reactions to mushrooms
  • History of allergic reaction to dextrin
  • History of allergic reaction to rapeseed oil
  • History of allergic reaction to corn
  • Consumption of other supplements derived from mushrooms or basidiomycetes
  • Consumption of whole mushrooms through diet is acceptable
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  • Consumption of a blend with unknown/ unclear mushrooms or basidiomycetes contents, then it is ok to include participant
  • Current or prior (within 3 months of enrollment) use of immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) agents). The following are exceptions to this criterion:
  • Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10 mg/day of prednisone or equivalent may be enrolled.
  • Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled.
  • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would interfere with patient safety or limit compliance with study requirements.
  • Inability to swallow experimental agent or placebo
  • History of gastrectomy or other malabsorption syndromes
  • Subjects who are pregnant or breast-feeding
  • Any condition that would prohibit the understanding or rendering of informed consent
  • Any medical condition that in the opinion of the investigator would interfere with the patient's safety or compliance while on trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: Feasibility Pilot Study of a Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®) on Quality of Life for Ovarian Cancer Patients on Adjuvant Chemotherapy

This is a pilot phase, randomized, double-blinded feasibility pilot study of AHCC in participants with ovarian cancer.

Read the detailed description

This is a pilot phase, randomized, double-blinded feasibility pilot study of AHCC in participants with ovarian cancer. 20 women who plan to undergo adjuvant chemotherapy for ovarian cancer at the University of California (UC) Davis Health Comprehensive Cancer Center will be enrolled and randomized 1:1 to receive AHCC (3 grams by mouth daily) or placebo during standard of care chemotherapy. HRQOL and adverse events will be assessed at baseline and during chemotherapy. The hypothesis is that a randomized controlled trial of AHCC supplementation for ovarian cancer patients on adjuvant chemotherapy is feasible.

Being tested
AHCC, Chemotherapy, Placebo
Keywords
AHCC, Standardized extract of cultured Lentinula edodes mycelia
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AHCCDietary supplement

    Also called A standardized extract of cultured Lentinula edodes mycelia

    AHCC is the cultured mycelia of Lentinula edodes mushrooms from the Basidiomycetes family.

  • ChemotherapyDrug

    Also called Platinum and taxane chemotherapy

    Chemotherapy will be administered per standard of care.

  • PlaceboOther

    Dextrin

Study groups in NCT05763199
Study groupRoleWhat they receive
Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®)ExperimentalAHCC 3g PO Daily
Receives: Dietary Supplement: AHCC; Drug: Chemotherapy
PlaceboPlacebo comparatorPlacebo PO Daily
Receives: Drug: Chemotherapy; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants consent and randomized to taking AHCC or placebo during adjuvant chemotherapy compared to to total number of ovarian cancer patients eligible for the trial following prescreening and participation invitation.

    Measured: Study activation to randomization of 20th participant

  2. Time required to randomize 20 participants

    Measured: Study activation to randomization of 20th participant.

  3. Proportion of participants that complete study treatment

    Measured: First dose through Cycle 3-6 post adjuvant chemotherapy; each cycle is 3 weeks

Secondary outcomes (6)

  1. Proportion of participants that adhere to taking study treatment

    Measured: First dose through Cycle 3-6 post adjuvant chemotherapy; each cycle is 3 weeks

  2. Adherence to taking study treatment for each participant

    Measured: First dose through Cycle 3-6 post adjuvant chemotherapy; each cycle is 3 weeks

  3. Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)

    All health-related quality of life assessments use a 5 point Likert-type scale and is scored based on a manual scoring template, some items are reverse scored; the higher the score, the better the quality of life.

    Measured: Baseline through 30d post last dose

  4. Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy/ Gynecologic Oncology Group - Neurotoxicity (FACT/ GOG-NTX)

    All health-related quality of life assessments use a 5 point Likert-type scale and is scored based on a manual scoring template, some items are reverse scored; the higher the score, the better the quality of life.

    Measured: Baseline through 30d post last dose

  5. Proportion of participants that adhere to completing the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

    All health-related quality of life assessments use a 5 point Likert-type scale and is scored based on a manual scoring template, some items are reverse scored; the higher the score, the better the quality of life.

    Measured: Baseline through 30d post last dose

  6. Participant experience self-reported in the acceptability questionnaire compared to self-reported anticipated acceptability

    The acceptability questionnaire measures the following ordinal data listed in order of most acceptable to least acceptable: strongly agree, agree, neutral, disagree, and strongly disagree.

    Measured: Baseline and at end of treatment (about 9-18 weeks post adjuvant chemotherapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start1 Aug 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763199
Sponsor's protocol ID
UCDCC#302
Status last verified
Mar 2026
First submitted
27 Jan 2023
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AHCC and Chemotherapy in people with Ovarian Epithelial Carcinoma and Fallopian Tube Carcinoma, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants consent and randomized to taking AHCC or placebo during adjuvant chemotherapy compared to to total number of ovarian cancer patients eligible for the trial following prescreening and participation invitation. (time frame: Study activation to randomization of 20th participant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05763199.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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